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Recall Observatory FDA recall evidence

Drug product

Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur INDIA, For BluePoint Laboratories NDC 68001-334-08

D-1413-2020

July 17, 2020

Class II

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 86053
Status
Terminated
Classification
Class II
Quantity
11,688 bottles
Official record key
drug-enforcement:D-1413-2020

Official wording

Reason: Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg

Code information: Lot # Q000232, exp. date 01/2022

Distribution pattern: Product was distributed to OH and may have been further distributed throughout the United States.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablets